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3/31/2011 @ 7:09AM6,031 views

Former FDA Chemist Named in Insider Trading Cases

On March 29, 2011, the United States Department of Justice unsealed a criminal complaint in the District of Maryland that charges Gaithersburg, MD residents Cheng Yi Liang, 57, and his son, Andrew Liang, 25, with conspiracy to commit securities and wire fraud, securities fraud and wire fraud relating to their trading in the securities of five companies:

Clinical Data Inc.,

Vanda Pharmaceuticals Inc.,

Progenics Pharmaceuticals Inc.,

Middlebrook Pharmaceuticals Inc. and

Momenta Pharmaceuticals Inc.

The Liangs were arrested at their residence and appeared in U.S. District Court in Maryland

NOTE: A criminal complaint, which is not an indictment, is merely an accusation, and a defendant is presumed innocent unless and until proven guilty beyond a reasonable doubt in a court of law.

FDA Chemist

Allegedly, since 1996, Cheng Yi Liang was employed as a chemist at the Food and Drug Administration’s (FDA’s) Office of New Drug Quality Assessment (NDQA), where he had access to the Document Archiving, Reporting, and Regulatory Tracking System (DARRTS), the FDA’s password-protected internal tracking system for new drug applications. The complaint alleges that through unauthorized means that included accessing DARRTS, Cheng Yi Liang reviewed confidential non-public documents (“inside information”) relating to whether and when certain drug applications would be approved.

Document Archiving, Reporting, and Regulatory Tracking System (DARRTS): A CDER information technology (IT) platform intended to replace many of CDER’s core tracking systems, including components of the Center-wide Oracle-based Management Information System (COMIS), the Division File System (DFS), and CDER Standard Letters and Forms (CSL). DARRTS is currently the archival system of record for all investigational new drug applications (INDs), Emergency Use Applications, drug master files, and TSIs. Ultimately, it will be the archival system of record for new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) as well.

[Note: CDER is the FDA's Center for Drug Evaluation and Research]

From approximately November 2007 through March 2011, Cheng Yi Liang and Andrew Liang allegedly realized at least $2.27 million in profits from the inside information by repeatedly trading in securities issued by companies with pending drug applications. The trading was executed in accounts held in the name of Andrew Liang, as well as several accounts in the names of four different nominees; thereafter, the proceeds were transferred to various bank and brokerage accounts benefitting the father and son.

Screen-Shot Software — the Gotcha!

Apparently, on Jan. 6, 2011, the Department of Health and Human Services, Office of the Inspector General (HHS-OIG) installed software on Cheng Yi Liang’s work computer that took screen shots from that computer. That data revealed Liang’s use of DARRTS to review information related to a pending drug application submitted by Clinical Data Inc. for an anti-depressant drug called Viibryd.

On Jan. 18, 2011, the software showed Liang had reviewed an internal FDA document recommending approval of Viibryd. Allegedly, within minutes after such access, several accounts controlled by Liang and his son purchased 4,875 shares of Clinical Data – ultimately the Liangs acquired 48,875 shares of Clinical Data before Viibryd’s approval was announced on Jan. 21, 2011. Thereafter, the Liangs sold their entire position for at least a $379,000 profit.

Similarly, it is alleged that the Liangs traded in advance of a May 6, 2009, announcement by Vanda Pharmaceuticals Inc., that the FDA had approved its drug Fanapt. Utilizing Andrew Liang’s account and several nominee accounts, the Liangs allegedly made a nearly 800 percent profit, netting more than $1 million.

Worst Case Scenario

The maximum penalties that the Liangs face are

conspiracy to commit securities and wire fraud: 5 years in prison and a fine of $250,000, or twice the gross gain from the offence.

wire fraud: 20 years in prison and a fine of $250,000, or twice the gross gain from the offence.

securities fraud: 20 years in prison and a fine of $5 million for each count.

In a related action, the Criminal Division’s Asset Forfeiture and Money Laundering Section (AFMLS) filed a civil complaint in the District of Maryland for forfeiture of proceeds from and property involved in the insider trading scheme, specifically, seven brokerage accounts, two bank accounts and two pieces of real property. Also, the Securities and Exchange Commission (SEC) filed a civil enforcement action against Cheng Yi Liang in the District of Maryland.

SEC v. Cheng Yi Liang, and a number of Relief Defendants

In the Securities and Exchange Commission v. Cheng Yi Liang, et al., (Civil Action No. 8:11-cv-00819-RWT (D. Md.)), the SEC Complaint charged Chen Yi Liang, 57, a former FDA chemist in its Center for Drug Evaluation and Research, with insider trading involving at least 27 public announcements about FDA drug approval decisions involving 19 publicly traded companies for illicit profits/avoided losses of at lease $3.6 million. In addition to Defendant Liang, the SEC’s Complaint names six Relief Defendants for the purpose of recovering allegedly ill-gotten funds to which they have no legitimate claim:

Yi Zhuge, age 54,is Liang’s wife and listed as the beneficiary on one of the brokerage accounts through which Liang traded and as having power of attorney over another. Some of the other brokerage accounts through which Liang traded were used to write checks to Zhuge, which were deposited in a bank account she shares with Liang.

Hui Juan Chen, age 84, is Liang’s mother, is a citizen of China with a permanent residence in Shanghai. Liang traded ahead of all 27 FDA drug approval announcements through a brokerage account in Hui Juan Chen’s name.

Zhongshan Chen, age 56, is a citizen of China with a permanent residence in China. Liang traded ahead of sixteen FDA drug approval announcements through two brokerage accounts in Zhongshan Chen’s name.

Shuhua Zhu, age 55, is listed on brokerage account documentation as residing in Rockville, Maryland. Liang traded ahead of five FDA drug approval announcements through a brokerage account in Shuhua Zhu’s name.

Honami Toda, age 53, is a citizen of Japan with a permanent residence in Japan. According to brokerage account documentation, she also has a residence in Rockville, Maryland. Liang traded ahead of seven FDA drug approval announcements through a brokerage account in Honami Toda’s name.

NOTE: The SEC Complaint is merely an accusation and the various defendants are presumed innocent unless and until proven guilty in a court of law.

As to the companies that were allegedly traded by Liang, the SEC sets forth the following list (Note: all securities are traded on the NASDAQ with the exception of Novadel Pharmaceuticals, Inc., which is traded on NYSE Amex; and all companies are/were Delaware corporations):

Adolor Corporation is headquartered in Exton, Pennsylvania. The company sponsored FDA review of the drug “Entereg.”

Anesiva, Inc. is headquartered in South San Francisco, California. The company sponsored FDA review of the drug “Zingo.”

Clinical Data, Inc. is headquartered in Newton, Massachusetts. The company sponsored FDA review of the drug “Viibryd.”

Connetics Corporation was headquartered in Palo Alto, California. The company sponsored FDA review of the drug “VersaFoam.”

Cornerstone Therapeutics, Inc. is headquartered in Cary, North Carolina. The company agreed to jointly promote the drug “Perforomist” with a company that sponsored its FDA review and sponsored FDA review of the drug “Zyflo.”.

CV Therapeutics, Inc. was headquartered in Palo Alto, California. The company sponsored FDA review of the drug “Lexiscan.”

Encysive Pharmaceuticals Inc. was headquartered in Houston, Texas. The company sponsored FDA review of the drug “Thelin.”

EPIX Pharmaceuticals, Inc. was headquartered in Lexington, Massachusetts. The company sponsored FDA review of the drug “Vasovist.”

MannKind Corp. is headquartered in Valencia, California. The company sponsored FDA review of the drug “Afrezza.”

Middlebrook Pharmaceuticals, Inc. was headquartered in Westlake, Texas. The company sponsored FDA review of the drug “Moxatag.”

Momenta Pharmaceuticals, Inc. is headquartered in Cambridge, Massachusetts. The company developed the drug “Enoxaparin” which FDA review was sponsored by a partner company.

Novadel Pharmaceuticals, Inc. is headquartered in Bridgewater, New Jersey. The company sponsored FDA review of the drugs “Xcytrin” and “ZolpiMist.”

Pharmacyclics, Inc. is headquartered in Sunnyvale, California. The company sponsored FDA review of the drug “Xcytrin.”

Pozen Inc. is headquartered in Chapel Hill, North Carolina The company sponsored FDA review of the drugs “Treximet” and “Vimovo.”

Progenics Pharmaceuticals, Inc. is headquartered in Tarrytown, New York. The company sponsored FDA review of the drug “Relistor.”

Santarus, Inc. is headquartered in San Diego, California. The company sponsored FDA review of the drug “Zegerid” and licensed the drug “Zegerid OTC” to another company that sponsored its FDA review.

Somaxon Pharmaceuticals, Inc. is headquartered in San Diego, California. The company sponsored FDA review of the drug “Silenor.”

Spectrum Pharmaceuticals is headquartered in Irvine, California. The company sponsored FDA review of the drug “LEVOleucovorin.”

Vanda Pharmaceuticals Inc. is headquartered in Rockville, Maryland. The company sponsored FDA review of the drug “Iloperidone.”

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